AzTrials
AzTrials

Intracerebral HemorrhagePhase 3ASPIRENCT03907046

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

A Phase 3 study testing Apixaban and Aspirin in people with Intracerebral Hemorrhage and Atrial Fibrillation, run by Yale University at 187 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage, Atrial Fibrillation
What is being tested?
Apixaban and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
187 sitesUnited States
Study dates
28 Jan 2020to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at least 18 years
  • Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  • Can be randomized within 14-180 days after ICH onset
  • Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
  • Provision of signed and dated informed consent form by patient or legally authorized representative
  • For females of reproductive potential: use of highly effective contraception

Who cannot join

  • Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
  • History of earlier ICH within 12 months preceding index event
  • Active infective endocarditis
  • Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent).
  • Previous or planned left atrial appendage closure
  • Clinically significant bleeding diathesis
Show all 15Show fewer
  • Serum creatinine ≥2.5 mg/dL
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
  • Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) that is chronic in the judgment of the investigator
  • Pregnant or breastfeeding
  • Known allergy to aspirin or apixaban
  • Concomitant participation in a competing trial
  • Considered by the investigator to have a condition that precludes safe or active participation in the trial
  • Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
  • ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Trial locations and contacts

187 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kevin N Sheth, MD contact

443-615-4729

kevin.sheth@yale.edu

Hooman Kamel, MD contact

646-962-8284

hok9010@med.cornell.edu

187 sites in 1 country

United States187 sites, 142 recruiting

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

    Larami MacKenzie, MD

    Recruiting

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

    Ahmed Itrat, MD

    Recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Dylan Jones, MD

    Recruiting

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

    Suspended

  • Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18103

    Withdrawn

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

    Withdrawn

  • NCH Hospital, Arlington Heights

    Arlington Heights, Illinois, 60005

    Mohammad Anadani, MD

    Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Daniel Schachter, MD

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Fadi Nahab, MD

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Fenwick Nichols, MD

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Sharon Poisson, MD

    Recruiting

  • St. David's Medical Center

    Austin, Texas, 78705

    Withdrawn

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

    Withdrawn

  • University of Alabama Hospital

    Birmingham, Alabama, 35294

    Angela Shapshak, MD

    Recruiting

  • Saint Alphonsus Regional Medical Center - Boise

    Boise, Idaho, 83706

    Lukas Clark, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Emiliya Melkumova, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Mariel Kozberg, MD

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Steven Feske, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Magdy Selim, MD

    Recruiting

  • Kings County Hospital Center

    Brooklyn, New York, 11203

    Susan Law, MD

    Recruiting

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Withdrawn

  • Maimonides Medical Center

    Brooklyn, New York, 11219

    Terminated

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

    Jennifer Frontera

    Recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14202

    Active, not recruiting

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

    Colin James Culbertson, MD

    Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

    Chris Commichau

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Lucian Maidan

    Recruiting

  • Eden Medical Center, Castro Valley

    Castro Valley, California, 94546

    Withdrawn

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

    Withdrawn

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

    Julia Carlson, MD

    Recruiting

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

    Christine Holmstedt, MD

    Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

    Withdrawn

  • Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Melanie Greenway, MD

    Recruiting

  • UVA Medical Center

    Charlottesville, Virginia, 22908

    Brad Worral, MD

    Recruiting

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

    Withdrawn

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Alejandro Vargas, MD

    Recruiting

  • University of Illinois Hospital

    Chicago, Illinois, 60612

    Ali Alaraj, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Rachel Mehendale, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Rob Stanton, MD

    Recruiting

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Chengyuan Feng, MD

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Ajay Arora, MD

    Recruiting

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

    Abhishek Ray, MD

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Agnieszka Ardelt, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Blake Buletko

    Recruiting

  • Arrowhead Regional Medical Center

    Colton, California, 92324

    Dan Miulli, MD

    Recruiting

  • University of Missouri Health Care

    Columbia, Missouri, 65212

    Farhan Siddiq, MD

    Recruiting

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

    Yousef Hannawi, MD

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Vivek Rai, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Withdrawn

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Suspended

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Withdrawn

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Withdrawn

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

    Suspended

  • Duke University Hospital

    Durham, North Carolina, 27710

    Dylan Ryan, MD

    Recruiting

  • JFK Medical Center

    Edison, New Jersey, 08820

    Navid Tabibzadeh, MD

    Recruiting

  • NYC Health + Hospitals/Elmhurst

    Elmhurst, New York, 11373

    Hazem Shoirah, MD

    Recruiting

  • Evanston Hospital

    Evanston, Illinois, 60201

    Mohammad Anadani, MD

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Saqib Chaudhry, MD

    Recruiting

  • McLaren Flint

    Flint, Michigan, 48532

    Withdrawn

  • Kaiser Permanente Fontana Medical Center

    Fontana, California, 92335

    Vaninder Chhabra

    Recruiting

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

    Mehdi Mehdi, MD

    Recruiting

  • Community Regional Medical Center of Fresno

    Fresno, California, 93720

    Mellekate Vishwas, MD

    Recruiting

  • St. Jude Medical Center

    Fullerton, California, 92835

    Ashish Nanda, MD

    Recruiting

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

    Withdrawn

  • Trinity Health Saint Mary's

    Grand Rapids, Michigan, 49503

    Withdrawn

  • Trinity Health Saint Mary's

    Grand Rapids, Michigan, 49503

    Muhammad Farooq, MD

    Recruiting

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

    Pramod Sethi, MD

    Recruiting

  • ECU Health Medical Center

    Greenville, North Carolina, 27834

    Shailesh Male, MD

    Recruiting

  • Greenville Hospital System

    Greenville, South Carolina, 29605

    Sanjeev Sivakumar, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Kaitlin Reilly-Kit, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Mark Alberts, MD

    Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Nandakumar Nagaraja, MD

    Recruiting

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

    Kazuma Nakagawa, MD

    Recruiting

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

    Withdrawn

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Britz Britz, MD

    Recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Andrew Barreto, MD

    Recruiting

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Lisa Nobel, MD

    Recruiting

  • University of Iowa Medical Center

    Iowa City, Iowa, 52242

    Amir Shaban, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Withdrawn

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Kimberly McPhearson, MD

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Terminated

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

    Kyle Carpenter, MD

    Recruiting

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37916

    S. Arthur Moore, MD

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Murali Kolikonda, MD

    Recruiting

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

    Suhas Gangadhara, MD

    Recruiting

  • UAMS Medical Center

    Little Rock, Arkansas, 77205

    Withdrawn

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07052

    Steven Shapiro, MD

    Recruiting

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

    Withdrawn

  • Los Alamitos Medical Center

    Los Alamitos, California, 90720

    Nirav Patel, MD

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Harsimran Brara, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Konrad Schlick, MD

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Latisha Sharma, MD

    Recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Isaac Abecassis, MD

    Recruiting

  • North Shore University Hospital

    Manhasset, New York, 11030

    Rohan Arora, MD

    Recruiting

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

    Christopher Horn, MD

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Sarkis Morales-Vidal, MD

    Recruiting

  • Methodist University Hospital

    Memphis, Tennessee, 38104

    Balaji Krishnaiah, MD

    Recruiting

  • Semmes Murphey Main Campus

    Memphis, Tennessee, 38120

    Neha Kumar, MD

    Recruiting

  • Jackson Memorial Hospital

    Miami, Florida, 33136

    Sebastian Koch

    Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Withdrawn

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Ganesh Asaithambi, MD

    Recruiting

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Oladi Bentho, MD

    Recruiting

  • University of South Alabama University Hospital

    Mobile, Alabama, 36604

    Taha Nisar, MD

    Recruiting

  • Doctors Medical Center Modesto, Modesto, CA

    Modesto, California, 95350

    James Jaffe, MD

    Recruiting

  • J.W. Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

    Amelia Adcock, MD

    Recruiting

  • McLaren Macomb

    Mount Clemens, Michigan, 48043

    Terminated

  • Vanderbilt University Hospital

    Nashville, Tennessee, 37232

    Deborah Kerrigan, MD

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Ephrem Teklemariam, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

    Guido Falcone, MD

    Recruiting

  • Ochsner Medical Center - Main Campus

    New Orleans, Louisiana, 70121

    Richard Zweifler

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Neha Dangayach, MD

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Neha Dangayach, MD

    Recruiting

  • NYP Columbia University Medical Center

    New York, New York, 10032

    Imama Naqvi, MD

    Recruiting

  • NYP Weill Cornell Medical Center

    New York, New York, 10065

    Hooman Kamel, MD

    Recruiting

  • Hoag Hospital Newport Beach

    Newport Beach, California, 92663

    Withdrawn

  • OU Medical Center

    Oklahoma City, Oklahoma, 73104

    Evgeny Sidorov

    Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Jeffrey Craig, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

    Pierre Fayad, MD

    Recruiting

  • UC Irvine Medical Center

    Orange, California, 92868

    Wengui Yu, MD

    Recruiting

  • Desert Regional Medical Center

    Palm Springs, California, 92262

    Kevin Attenhofer, MD

    Recruiting

  • Huntington Memorial Hospital

    Pasadena, California, 91105

    Withdrawn

  • Ascension Sacred Heart Pensacola

    Pensacola, Florida, 32504

    Terry Neill, MD

    Recruiting

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

    Arun Talkad

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Aaron Rothstein, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Withdrawn

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Paul Katz, MD

    Recruiting

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

    Withdrawn

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Marcelo Rocha

    Recruiting

  • Cleveland Clinic Tradition Hospital

    Port Saint Lucie, Florida, 34987

    Marc Babi, MD

    Recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Teresa May, MD

    Recruiting

  • Oregon Health & Science University Hospital

    Portland, Oregon, 92739

    Wayne Clark

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97213

    John Zurasky

    Recruiting

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

    Terminated

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Terminated

  • Kaiser Permanente Redwood City Medical Center, Redwood City, CA

    Redwood City, California, 94063

    Sheila Chan, MD

    Recruiting

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

    Amandeep Sangha, MD

    Recruiting

  • VCU Medical Center

    Richmond, Virginia, 23298

    Suspended

  • Strong Memorial Hospital

    Rochester, New York, 14642

    Curtis Benesch, MD

    Recruiting

  • Javon Bea Hospital - Riverside

    Rockford, Illinois, 61114

    Withdrawn

  • UC Davis Medical Center

    Sacramento, California, 95817

    Kwan Ng, MD

    Recruiting

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

    Yekaterina Axelrod, MD

    Recruiting

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

    Muhammad Fareed Suri, MD

    Recruiting

  • HealthPartners Methodist Hospital

    Saint Louis Park, Minnesota, 55426

    Active, not recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Terminated

  • United Hospital, St. Paul

    Saint Paul, Minnesota, 55102

    Withdrawn

  • University of Utah Healthcare

    Salt Lake City, Utah, 84112

    Nabeel Chauhan, MD

    Recruiting

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

    Reza Behrouz, MD

    Recruiting

  • San Francisco General Hospital

    San Francisco, California, 94110

    Claude Hemphill, MD

    Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

    Brian Walcott, MD

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Withdrawn

  • Harborview Medical Center

    Seattle, Washington, 98104

    David Tirschwell, MD

    Recruiting

  • Swedish Medical Center - Cherry Hill Campus

    Seattle, Washington, 98122

    Withdrawn

  • Avera Research Institute

    Sioux Falls, South Dakota, 57108

    Jonathon Cooke, MD

    Recruiting

  • St. John's Hospital

    Springfield, Illinois, 62769

    Withdrawn

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Gottfried Schlaug, MD

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Brenton Coger, MD

    Recruiting

  • Cox Medical Center South

    Springfield, Missouri, 65807

    Benjamin Lisle, MD

    Recruiting

  • PeaceHealth Sacred Heart Medical Center - RiverBend

    Springfield, Oregon, 97477

    Mariam Tsikvadze, MD

    Recruiting

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

    Yan Wang, MD

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Venkat Chintapally-Rao, MD

    Recruiting

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

    Nida Jamal, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94304

    Chitra Venkat, MD

    Recruiting

  • Staten Island University Hospital - North Campus

    Staten Island, New York, 10305

    Withdrawn

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Jason Mathew, MD

    Recruiting

  • Overlook Medical Center

    Summit, New Jersey, 07901

    Marianna Atiya, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Julius-Gene Latorre, MD

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Swetha Renati, MD

    Recruiting

  • St. Joseph's Hospital

    Tampa, Florida, 33607

    Abilash Haridas, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Kathryn Kirchoff-Torres, MD

    Recruiting

  • Munson Medical Center

    Traverse City, Michigan, 49684

    Ramiro Castro-Apolo, MD

    Recruiting

  • Capital Health Regional Medical Center

    Trenton, New Jersey, 08638

    Withdrawn

  • Banner University Medical Center

    Tucson, Arizona, 85719

    Firas Kaddouh, MD

    Recruiting

  • Ascension St. John Medical Center

    Tulsa, Oklahoma, 74104

    Rahul Rahangdale, MD

    Recruiting

  • St. John Medical Center

    Tulsa, Oklahoma, 74104

    Rahul Rahangdale, MD

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Stephan Mayer, MD

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Douglas Mayson, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Withdrawn

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

    Fernando Mayor Basto, MD

    Recruiting

  • Burke Rehabilitation Center

    White Plains, New York, 10605

    Kathryn Kirchoff-Torres, MD

    Recruiting

  • PIH Health Hospital - Whittier

    Whittier, California, 90602

    Gautam Ganguly, MD

    Recruiting

  • New Hanover Regional Medical Center

    Wilmington, Delaware, 28403

    James McKinney, MD

    Recruiting

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28403

    Amanda Pardon, MD

    Recruiting

  • Central DuPage Hospital

    Winfield, Illinois, 60190

    Dhruvil Pandya, MD

    Recruiting

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

    Mitchell Hargis, MD

    Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Stacey Wolfe, MD

    Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

    Majaz Moonis, MD

    Recruiting

  • Metro Health Hospital

    Wyoming, Michigan, 49519

    Withdrawn

Other trials in United States

About this study

Official title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Read the detailed description

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF. Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

Being tested
Apixaban, Aspirin
Medical subject headings
Cerebral Hemorrhage, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called Eliquis

    Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.

  • AspirinDrug

    Aspirin is an oral antiplatelet drug.

Study groups in NCT03907046
Study groupRoleWhat they receive
ApixabanActive comparatorApixaban dosing will be 5 mg tablet in morning and 5 mg tablet in evening. A reduced dose of 2.5 mg tablet in morning and 2.5 mg tablet in evening will be used if: (1) ≥2 of the following are present: age ≥80 years, body weight ≤60 kg, or serum creatinine 1.5-2.4 mg/dL, or (2) Patient is taking a strong CYP3A4/pGP inhibitor (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).
Receives: Drug: Apixaban
AspirinPlacebo comparatorAspirin dose will be 81 mg tablet once daily.
Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke or death

    Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause

    Measured: Up to 3 years

Secondary outcomes (1)

  1. Modified Rankin Scale (mRS) score

    Measure of neurologic disability (0=no disability to 6=dead)

    Measured: Change from baseline to 12 months; change over duration of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2019
  2. Study start28 Jan 2020
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03907046
Sponsor's protocol ID
2000026409
Other IDs
1U01NS106513-01A1
Acronym
ASPIRE
Status last verified
May 2026
First submitted
4 Apr 2019
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.

    PubMed 36700520

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban and Aspirin in people with Intracerebral Hemorrhage and Atrial Fibrillation, run by Yale University at 187 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin N Sheth, MD (443-615-4729, kevin.sheth@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke or death (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907046, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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